Quality of life outcomes
| Saline washouts (n=26) | Acidic washouts (n=27) | Control (n=27) | |
| EQ-5D-5L* | |||
| Baseline | 0.368 (0.405); (n=25) | 0.365 (0.359); (n=26) | 0.348 (0.373); (n=27) |
| 6 months | 0.356 (0.513); (n=18) | 0.335 (0.313); (n=20) | 0.270 (0.348); (n=22) |
| 12 months | 0.386 (0.430); (n=18) | 0.412 (0.321); (n=17) | 0.339 (0.414); (n=21) |
| 18 months | 0.493 (0.403); (n=10) | 0.302 (0.453); (n=7) | 0.139 (0.264); (n=8) |
| 24 months | 0.349 (0.414); (n=4) | 0.621 (0.339); (n=3) | −0.077 (0.082); (n=4) |
| Exit | 0.445 (0.541); (n=6) | 0.327 (0.491); (n=4) | 0.229 (0.211); (n=4) |
| Effect size compared with control | 0.056 (−0.022 to 0.134); 0.11 | 0.053 (−0.024 to 0.131); 0.12 | |
| GSE Scale† | |||
| Baseline | 29.1 (9.1); (n=25) | 29.4 (5.7); (n=27) | 27.8 (7.6); (n=27) |
| 6 months | 27.7 (9.3); (n=19) | 27.6 (6.0); (n=20) | 26.8 (8.5); (n=23) |
| 12 months | 27.4 (9.7); (n=18) | 29.2 (5.5); (n=18) | 25.1 (7.5); (n=21) |
| 18 months | 28.3 (7.7); (n=9) | 29.3 (6.0); (n=8) | 28.3 (3.6); (n=9) |
| 24 months | 28.3 (3.3); (n=4) | 30.4 (4.9); (n=4) | 27.3 (7.4); (n=4) |
| Effect size compared with control | 0.9 (−1.5 to 3.2); 0.40 | 2.2 (−0.1 to 4.5); 0.030 | |
| ICECAP-A‡ | |||
| Baseline | 0.551 (0.216); (n=10) | 0.487 (0.223); (n=11) | 0.496 (0.218); (n=9) |
| 6 months | 0.671 (0.176); (n=8) | 0.592 (0.256); (n=10) | 0.620 (0.200); (n=8) |
| 12 months | 0.606 (0.233); (n=7) | 0.450 (0.282); (n=7) | 0.611 (0.146); (n=7) |
| 18 months | 0.849 (0.000); (n=2) | 0.246 (0.349); (n=2) | 0.669 (0.203); (n=4) |
| 24 months | 0.766 (0.117); (n=2) | 0.304 (0.281); (n=3) | 0.486 (0.137); (n=2) |
| Effect size compared with control | −0.076 (−0.221 to 0.068); 0.24 | −0.086 (−0.214 to 0.042); 0.13 | |
| ICECAP-O‡ | |||
| Baseline | 0.488 (0.320); (n=15) | 0.601 (0.206); (n=14) | 0.669 (0.204); (n=15) |
| 6 months | 0.554 (0.268); (n=12) | 0.657 (0.227); (n=11) | 0.673 (0.241); (n=15) |
| 12 months | 0.569 (0.329); (n=11) | 0.611 (0.239); (n=9) | 0.707 (0.161); (n=13) |
| 18 months | 0.511 (0.239); (n=7) | 0.614 (0.331); (n=6) | 0.666 (0.230); (n=5) |
| 24 months | 0.637 (0.078); (n=2) | 0.940 (n/a); (n=1) | 0.641 (0.219); (n=2) |
| Effect size compared with control | 0.036 (−0.069 to 0.142); 0.44 | −0.038 (−0.145 to 0.070); 0.43 | |
| ICIQ-LTC function and concern§ | |||
| Baseline | 18.3 (9.1); (n=26) | 17.3 (9.7); (n=26) | 19.1 (9.0); (n=27) |
| 6 months | 15.6 (10.1); (n=19) | 16.4 (10.2); (n=19) | 19.8 (9.6); (n=23) |
| 12 months | 12.5 (6.9); (n=15) | 18.1 (11.6); (n=15) | 17.9 (10.7); (n=20) |
| 18 months | 11.9 (5.5); (n=7) | 12.3 (7.5); (n=7) | 14.2 (12.5); (n=6) |
| 24 months | 9.3 (3.3); (n=4) | 19.5 (4.4); (n=4) | 18.5 (10.0); (n=4) |
| Effect size compared with control | −1.2 (-4.1 to 1.7); 0.34 | 0.7 (-2.2 to 3.5); 0.60 | |
| ICIQ-LTC lifestyle§ | |||
| Baseline | 6.7 (3.4); (n=24) | 8.1 (3.3); (n=27) | 7.6 (2.9); (n=27) |
| 6 months | 7.4 (3.8); (n=19) | 7.6 (4.0); (n=17) | 8.4 (3.2); (n=21) |
| 12 months | 7.8 (4.3); (n=16) | 8.1 (3.7); (n=14) | 8.4 (3.6); (n=20) |
| 18 months | 7.0 (2.6); (n=8) | 10.0 (3.5); (n=7) | 7.3 (3.4); (n=6) |
| 24 months | 7.5 (2.1); (n=2) | 8.8 (4.2); (n=4) | 5.3 (2.9); (n=4) |
| Effect size compared with control | −0.1 (−1.6 to 1.4); 0.90 | −0.4 (−1.9 to 1.2); 0.60 | |
| Treatment Satisfaction Questionnaire | |||
| Effectiveness¶ | |||
| 6 months | 67.0 (27.9); (n=17) | 67.6 (31.3); (n=18) | |
| 12 months | 74.2 (30.5); (n=14) | 71.8 (18.9); (n=14) | |
| 18 months | 83.3 (22.9); (n=5) | 77.8 (21.2); (n=5) | |
| 24 months | 83.3 (23.6); (n=2) | 77.8 (25.5); (n=3) | |
| Convenience¶ | |||
| 6 months | 82.0 (15.3); (n=17) | 73.8 (23.3); (n=18) | |
| 12 months | 89.7 (11.3); (n=14) | 77.0 (18.9); (n=14) | |
| 18 months | 90.7 (13.5); (n=6) | 80.0 (18.7); (n=5) | |
| 24 months | 91.7 (3.9); (n=2) | 74.1 (8.5); (n=3) | |
| Overall satisfaction¶ | |||
| 6 months | 76.1 (22.7); (n=17) | 78.2 (27.7); (n=17) | |
| 12 months | 86.7 (20.2); (n=14) | 73.0 (29.5); (n=14) | |
| 18 months | 88.1 (22.9); (n=6) | 84.3 (27.4); (n=5) | |
| 24 months | 75.0 (15.2); (n=2) | 69.0 (28.9); (n=3) | |
The EQ-5D-5L exit questionnaire was for participants who exited the study early or were not at a notional follow-up point when the study ended.
All effect sizes are derived from a mixed effects linear regression, including fixed effects for the two treatment groups, gender, age band, previous blockage, previous S-CAUTI and baseline measure of the outcome. Dummy variables are also included for the timepoint at which follow-up is completed. Random effects (intercepts) are included for region and participant to account for repeated measures over time. The summary statistics are the mean, SD and count, and the effects sizes presented as the adjusted mean difference, 97.5% CI and p-value.
*The EQ-5D-5L is a generic QoL measure. It has five questions and is on a scale from −0.594 to 1, with higher scores indicating better QoL.
†The GSE Scale assesses ability to cope with daily life. It has 10 questions and scores range from 10 to 40, with higher scores indicating better outcomes.
‡The ICECAP-A and ICEPOP-O measure capability in adults and older people, respectively. Both consist of five questions and are on a scale from 0 to 1, with higher scores indicating better outcomes.
§The ICIQ Long-Term Catheterisation Quality of Life Questionnaire is a specific quality of life measure. It produces the function and concern score and the lifestyle score. The function and concern score consists of 10 questions and is on a scale from 0 to 42. The lifestyle score consists of three questions and is on a scale from 3 to 15. For both scores, higher values indicate worse outcomes.
¶The Treatment Satisfaction Questionnaire assesses satisfaction with medication. It produces three scores: effectiveness, convenience and overall satisfaction. Each score consists of three questions for a total of nine questions, with each score on a scale from 0 to 100, where higher scores indicate better satisfaction.
EQ-5D-5L, EuroQoL 5-Dimension 5-Level; GSE, General Self-Efficacy; ICIQ-LTC, International Consultation on Incontinence Modular Questionnaire-LTC; QoL, quality of life.